510(k) K912244
K912244 is an FDA 510(k) premarket notification submitted by In Wha Pharmaceutical Co., Ltd. for the device "UROTEST GPH". The FDA issued a decision of Substantially Equivalent on November 22, 1991. The device falls under product code JII (Atomic Absorption, Lithium), a Class II device regulated under 21 CFR 862.3560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1991
- Date Received
- May 21, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Atomic Absorption, Lithium
- Device Class
- Class II
- Regulation Number
- 862.3560
- Review Panel
- TX
- Submission Type